Auditory Verbal HallucinationsNCT01801787
Non-invasive Brain Stimulation for Auditory Verbal Hallucinations in Schizophrenia
A study testing tDCS in people with Auditory Verbal Hallucinations and Schizophrenia, run by Charite University, Berlin, Germany at 2 sites in Germany.
Trial summary
The current study investigates the basic principles that underlie the efficacy of transcranial direct current stimulation for chronic auditory verbal hallucinations in schizophrenia in a multimodal design. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Auditory Verbal Hallucinations, Schizophrenia
- What is being tested?
- tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesGermany
- Study dates
- Mar 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of schizophrenia
- chronic auditory verbal hallucinations
- right-handed
Who cannot join
- drug abuse other than nicotine
- severe cognitive deficits
- severe medical conditions
- severe neurological disorders
- severe microangiopathy
- history of electroconvulsive therapy
- pregnancy or lactation
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Charité University Medicine
Berlin, 10117
Charité University Medicine
Berlin, 12203
About this study
Official title: The Mechanism of Non-invasive Brain Stimulation for Therapy of Chronic Auditory Verbal Hallucinations in Schizophrenia
The current study investigates the basic principles that underlie the efficacy of transcranial direct current stimulation for chronic auditory verbal hallucinations in schizophrenia in a multimodal design.
- Conditions
- Auditory Verbal Hallucinations, Schizophrenia
- Being tested
- tDCS
- Medical subject headings
- Hallucinations, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
Also called device: neuroConn tDCS PLUS device
active vs. sham tDCS left hemisphere
| Study group | Role | What they receive |
|---|---|---|
| verum tDCS | Experimental | left-hemispheric tDCS: anode placed midway between F3 and FP1, cathode placed midway between T3 and P3 Receives: Device: tDCS |
| sham tDCS | Sham comparator | left-hemispheric sham tDCS: anode placed midway between F3 and FP1, cathode placed midway between T3 and P3 Receives: Device: tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Auditory Hallucination Rating Scale score
Auditory Hallucination Rating Scale score will be assessed at baseline; changes thereof at 3 days after intervention and 3 months after intervention are primary outcome measures
Measured: baseline; 3 days after intervention; 3 months after intervention
Secondary outcomes (1)
Positive And Negative Syndrome Scale
Positive And Negative Syndrome Scale score will be assessed at baseline; changes thereof at 3 days after intervention and 3 months after intervention are secondary outcome measures
Measured: baseline; 3 days after intervention; 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Auditory Verbal HallucinationsStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andres Neuhaus, MD, Charite University, Berlin, Germany
- Investigators
- Robert Lindenberg, MD, Principal investigator, Department of Neurology, Charité University Medicine BerlinAndres H. Neuhaus, MD, Principal investigator, Department of Psychiatry, Charité University Medicine Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01801787
- Sponsor's protocol ID
- EA4/123/12
- Status last verified
- Aug 2016
- First submitted
- 26 Feb 2013
- Last updated
- 16 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mechanism of Non-invasive Brain Stimulation for Therapy of Chronic Auditory Verbal Hallucinations in Schizophrenia
- ClinicalTrials.gov ID
- NCT01801787
- Acronym / sponsor ID
- EA4/123/12
- Conditions
- Auditory Verbal Hallucinations, Schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 1 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current study investigates the basic principles that underlie the efficacy of transcranial direct current stimulation for chronic auditory verbal hallucinations in schizophrenia in a multimodal design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| verum tDCS | Experimental | Device: tDCSleft-hemispheric tDCS: anode placed midway between F3 and FP1, cathode placed midway between T3 and P3 |
| sham tDCS | Sham comparator | Device: tDCSleft-hemispheric sham tDCS: anode placed midway between F3 and FP1, cathode placed midway between T3 and P3 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosis of schizophrenia
- chronic auditory verbal hallucinations
- right-handed
Key exclusion criteria (7 listed)
- drug abuse other than nicotine
- severe cognitive deficits
- severe medical conditions
- severe neurological disorders
- severe microangiopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCSAlso: device: neuroConn tDCS PLUS deviceactive vs. sham tDCS left hemisphere | Device | sham tDCS, verum tDCS |
Primary outcome
Change of Auditory Hallucination Rating Scale score
Time frame: baseline; 3 days after intervention; 3 months after intervention
Auditory Hallucination Rating Scale score will be assessed at baseline; changes thereof at 3 days after intervention and 3 months after intervention are primary outcome measures
1 secondary outcome
Positive And Negative Syndrome Scale
Time frame: baseline; 3 days after intervention; 3 months after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2016.
Related trials for Auditory Verbal Hallucinations
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DecNef for Auditory Verbal Hallucinations (AVH) in Schizophrenia
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Neuronavigated rTMS for Treatment-Resistant Auditory Hallucinations
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Reduction of Auditory-Verbal Hallucinations in Schizophrenia Through Cortical Neuromodulation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Lindenberg, MD principal investigator
Department of Neurology, Charité University Medicine Berlin
Andres H. Neuhaus, MD principal investigator
Department of Psychiatry, Charité University Medicine Berlin
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS in people with Auditory Verbal Hallucinations and Schizophrenia, run by Charite University, Berlin, Germany at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Auditory Hallucination Rating Scale score (time frame: baseline; 3 days after intervention; 3 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2016.